Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-09

Study Completion Date

2023-01-30

Brief Summary

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The purpose of the study is to evaluate if the implementation of a multimedia based educational tool and regular reminders with shared decision-making will increase the rate of LARC uptake and retention in high risk pregnancy patients within 12 weeks of delivery and to study the rates of retention of LARC at 12 and 24 months and short-interval pregnancy rates.

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Detailed Description

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This study will include 380 women aged 18-50 enrolled between 28 weeks gestation and postpartum day #1 who have a pregnancy that is considered high-risk. After consent, participants will be randomized to either routine care or multimedia based intervention. The intervention will include an investigator created decision aid presented at the time of randomization and reminder texts until 12 weeks postpartum.

The primary objective is to evaluate the rate of LARC uptake and retention within 12 weeks of delivery. Secondary objectives include i) the retention of LARC at 12 and 24 months and ii) short-interval pregnancy rates.

Conditions

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Pregnancy, High Risk Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Decision Aid

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

Following randomization, participants will independently view the multimedia based decision aid on a provided tablet. They will also receive provider counseling. For the remainder of the pregnancy, they will receive a text message with a link to the multimedia based presentation. This will occur every 4 weeks until 12 weeks postpartum.

Routine Care

Group Type ACTIVE_COMPARATOR

Routine Care

Intervention Type BEHAVIORAL

The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options.

Interventions

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Decision Aid

Following randomization, participants will independently view the multimedia based decision aid on a provided tablet. They will also receive provider counseling. For the remainder of the pregnancy, they will receive a text message with a link to the multimedia based presentation. This will occur every 4 weeks until 12 weeks postpartum.

Intervention Type BEHAVIORAL

Routine Care

The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 13-50 years old
* High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications

Exclusion Criteria

* Planned cesarean hysterectomy
* Unable to provide informed consent in either English or Spanish
* Unable to provide reliable cell phone access for the study duration
* Not willing to provide follow-up for two years

Minimum Eligible Age

13 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No